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Clinical Trial of Prostatic Arterial Embolization Versus a Sham Procedure to Treat Benign Prostatic Hyperplasia

Primary Purpose

Prostatic Hyperplasia, Benign, Prostatic Hypertrophy, Benign, Genital Diseases, Male

Status

Completed

Phase

Not Applicable

Locations

Portugal

Study Type

Interventional

Intervention

Prostatic Arterial Embolization

Sham procedure

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia, Benign focused on measuring Prostatism, Randomized Controlled Trial, Embolization, Therapeutic, Hyperplasia, Prostatic Diseases, Genital Diseases, Male

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male patients ≥ 45 years-old
Diagnosis of BPH based on clinical history, digital rectal examination, urine sediment, transrectal prostate ultrasound and PSA
Use of a marketed alpha-blocker for LUTS/BPH in the previous 6 months
Severe lower urinary tract symptoms at screening and baseline defined by all the following: IPSS (7 items) ≥ 20, QoL ≥ 3, Qmax < 12 mL/s and prostate volume ≥ 40 mL
CTA shows that prostatic arteries are feasible for PAE
Sexual dysfunction or accepting the risk of developing sexual dysfunction after treatment
Written informed consent

Exclusion Criteria:

Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment
Acute or chronic prostatitis or suspected prostatitis including chronic pain, intermittent pain or abnormal sensation in the penis, testis, anal or pelvic area in the past 12 months
History of prostate or bladder cancer or pelvic irradiation
Active or recurrent urinary tract infections (more than 1 episode in the last 12 months)
History of neurogenic bladder or LUTS secondary to neurological disease
Advanced atherosclerosis and tortuosity of iliac and prostatic arteries
Secondary renal insufficiency (due to prostatic obstruction)
Large bladder diverticula or stones
Detrusor failure
Previous history of acute urinary retention
Current severe, significant or uncontrolled disease (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal, uncontrolled hypertension (systolic ≥ 160 mmHg and/or diastolic ≥95 mmHg), congestive heart failure [New York Heart Association status of class III or IV], myocardial infarction within 26 weeks prior to randomization), which in the judgment of the clinical investigator renders the subject unsuitable for the trial and puts the subject at increased risk
Any bleeding disorder such as hemophilia, clotting factor deficiency, anti-coagulation or bleeding diathesis
Hypersensitivity or contraindication to tamsulosin use
Administration of 5-ARIs, finasteride and dutasteride in the previous 2 weeks and 4 months, respectively. These patients may be included if they stop those medications and replace them for tansulosin, alfuzosin or silodosin for at least 2 weeks and 4 months, respectively.
Any mental condition or disorder that would interfere with the subject's ability to provide informed consent
Participation in a study of any investigational drug or device in the previous 3 months

Sites / Locations

Hospital de Saint Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Prostatic Arterial Embolization

Sham procedure

Arm Description

Selective catheterization of the prostatic arteries followed by slow injection of Bead Block 300-500 or PVA 100+200 micra particles under fluoroscopic control.

Selective catheterization of the prostatic arteries followed by removal of the catheter with no particles injected.

Outcomes

Primary Outcome Measures

Change from baseline in the International Prostate Symptom Score

The difference between the baseline value and the value observed at the last valid observation of a validated questionnaire that measures the disconfort caused by lowere urinary tract symptoms

Secondary Outcome Measures

Disease specific quality of life question of the International Prostate Symptom Score

The score of a question on the IPSS questionnare that measures quality of life in subjects with lower urinary tract symptoms at the last valid observation in each subject

Full Information

NCT ID

NCT02074644

First Posted

February 26, 2014

Last Updated

February 13, 2020

Sponsor

João Martins Pisco

1. Study Identification

Unique Protocol Identification Number

NCT02074644

Brief Title

Clinical Trial of Prostatic Arterial Embolization Versus a Sham Procedure to Treat Benign Prostatic Hyperplasia

Official Title

Randomized, Evaluator-blind, Controlled Trial to Evaluate the Efficacy and Safety of Prostatic Arterial Embolization Versus a Sham Procedure for Benign Prostatic Hyperplasia With Severe LUTS Not Adequately Controlled With Alpha-blockers

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

September 2, 2014 (Actual)

Primary Completion Date

March 3, 2019 (Actual)

Study Completion Date

March 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

João Martins Pisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether prostatic arterial embolization (PAE) compared is an effective and safe treatment for benign prostatic hyperplasia in patients with severe lower urinary tract symptoms not adequately controlled by medical therapy with alpha-blockers, as assessed by the the International Prostate Symptom Score (IPSS) after 6 months. Patients will be randomized on a 1:1 ratio to PAE or to a sham procedure and evaluated at 1, 3 and 6 months. Patients randomized to the sham procedure will be offered the possibility of performing PAE after 6 months. All patients may participate on an optional 6-months extension study.

Detailed Description

This is a randomized, parallel-group, evaluator-blind, superiority, controlled clinical trial of PAE versus a sham procedure in patients with BPH with severe LUTS not adequately controlled by medical therapy with alpha-blockers. This study has a screening visit at day -14, a baseline visit at day -2, a randomization and intervention visit at day 0, follow up visits at months 1, 3 and 6. Patients initially randomized to the sham procedure and who completed the 6 month follow-up period will be offered the possibility of performing PAE at no cost. All patients will be invited to participate in a 6 months post-trial extension study. Patients over 45 years-old with a diagnosis of BPH associated with severe LUTS defined by an IPSS>=20 after a minimum of 6 months treatment with alpha-blockers and with a prostate volume ≥ 40 mL will start a two weeks screening period. Eligible patients will be started either tamsulosin 0.4 mg q.d., alfuzosin 10 mg q.d. or silodosin 8 mg q.d., which will be maintained throughout the study period, and have the intervention scheduled for the following 2 days (study day 0), when they will be randomized to PAE or to a sham procedure if the procedure is technically feasible Those patients in whom angiography has shown that PAE is technically feasible will be randomized to one of the study arms on a 1:1 ratio. Patients in both groups will be submitted to exactly the same procedure, except that patients randomized to the control group will not be injected with polyvinyl alcohol particles. Patients will be discharged as soon as their clinical condition is stabilized Patients will be assessed at 1, 3 and 6 months with IPSS, QoL, IIEF, BPH-II and will perform prostatic ultrasonography, uroflowmetry and PSA at month 1 and 6. At 1 month a pelvic NMR will be performed to evaluate prostate volume and the degree of ischemia. Patients completing the 6 month follow-up period will be invited to enter a 6 months extension study. In this extension study, patients will be evaluated at month 12 for all efficacy variables. Patients initially randomized to the sham procedure who wanted to perform PAE after the conclusion of the trial will be evaluated only at months 1, 3 and 6 after PAE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Hyperplasia, Benign, Prostatic Hypertrophy, Benign, Genital Diseases, Male, Lower Urinary Tract Symptoms, Prostatic Diseases

Keywords

Prostatism, Randomized Controlled Trial, Embolization, Therapeutic, Hyperplasia, Prostatic Diseases, Genital Diseases, Male

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prostatic Arterial Embolization

Arm Type

Experimental

Arm Description

Selective catheterization of the prostatic arteries followed by slow injection of Bead Block 300-500 or PVA 100+200 micra particles under fluoroscopic control.

Arm Title

Sham procedure

Arm Type

Sham Comparator

Arm Description

Selective catheterization of the prostatic arteries followed by removal of the catheter with no particles injected.

Intervention Type

Procedure

Intervention Name(s)

Prostatic Arterial Embolization

Intervention Description

The prostatic arteries are selectively catheterized with a Progreat 2.7 microcatheter and an angiography is performed to confirm that the catheter is in the prostatic artery. Bead Block 300-500 or PVA 100+200 micra particles are slowly injected under fluoroscopic control until the end point is reached. Embolization is considered finished when there is "near stasis" in the prostatic vessels with interruption of the arterial flow and prostatic gland opacification checked in both oblique and AP views. Upon finishing the embolization of the left prostatic arteries, the right prostatic arteries are embolized in the same way.

Intervention Type

Procedure

Intervention Name(s)

Sham procedure

Intervention Description

The prostatic arteries are selectively catheterized with a Progreat 2.7 microcatheter and an angiography is performed to confirm that the catheter is in the prostatic artery. The catheter is removed and no particles are injected.

Primary Outcome Measure Information:

Title

Change from baseline in the International Prostate Symptom Score

Description

The difference between the baseline value and the value observed at the last valid observation of a validated questionnaire that measures the disconfort caused by lowere urinary tract symptoms

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Disease specific quality of life question of the International Prostate Symptom Score

Description

The score of a question on the IPSS questionnare that measures quality of life in subjects with lower urinary tract symptoms at the last valid observation in each subject

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Change from baseline in the Benign Prostatic Hyperplasia Impact Index (BPH-II)

Description

The difference between the baseline value and the value observed at the last valid observation on a validated questionnaire that measures the disconfort caused by lowere urinary tract symptoms

Time Frame

6 months

Title

Change from baseline in the International Index of Erectile Function (IIEF)

Description

The difference between the baseline value and the value observed at the last valid observation on a validated questionnaire that measures the severity of erectile disfunction

Time Frame

6 months

Title

Change from baseline in the peak urinary flow rate (Qmax)

Description

The difference between the baseline value and the value observed at the last valid observation of the maximum flow rate of the urinary stream by uroflowmetry

Time Frame

6 months

Title

Change from baseline in the post-void residual volume

Description

TThe difference between the baseline value and the value observed at the last valid observation of he volume of urine in the bladder after a complete voiding assessed by uroflowmetry

Time Frame

6 months

Title

Change from baseline in prostate volume

Description

The difference between the baseline value and the value observed at the last valid observation of prostate volume measured by transrectal ultrasonography

Time Frame

6 months

Title

Change from baseline in the Prostate Specific Antigen (PSA)

Description

The difference between the baseline value and the value observed at the last valid observation of PSA.

Time Frame

6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male patients ≥ 45 years-old Diagnosis of BPH based on clinical history, digital rectal examination, urine sediment, transrectal prostate ultrasound and PSA Use of a marketed alpha-blocker for LUTS/BPH in the previous 6 months Severe lower urinary tract symptoms at screening and baseline defined by all the following: IPSS (7 items) ≥ 20, QoL ≥ 3, Qmax < 12 mL/s and prostate volume ≥ 40 mL CTA shows that prostatic arteries are feasible for PAE Sexual dysfunction or accepting the risk of developing sexual dysfunction after treatment Written informed consent Exclusion Criteria: Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment Acute or chronic prostatitis or suspected prostatitis including chronic pain, intermittent pain or abnormal sensation in the penis, testis, anal or pelvic area in the past 12 months History of prostate or bladder cancer or pelvic irradiation Active or recurrent urinary tract infections (more than 1 episode in the last 12 months) History of neurogenic bladder or LUTS secondary to neurological disease Advanced atherosclerosis and tortuosity of iliac and prostatic arteries Secondary renal insufficiency (due to prostatic obstruction) Large bladder diverticula or stones Detrusor failure Previous history of acute urinary retention Current severe, significant or uncontrolled disease (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal, uncontrolled hypertension (systolic ≥ 160 mmHg and/or diastolic ≥95 mmHg), congestive heart failure [New York Heart Association status of class III or IV], myocardial infarction within 26 weeks prior to randomization), which in the judgment of the clinical investigator renders the subject unsuitable for the trial and puts the subject at increased risk Any bleeding disorder such as hemophilia, clotting factor deficiency, anti-coagulation or bleeding diathesis Hypersensitivity or contraindication to tamsulosin use Administration of 5-ARIs, finasteride and dutasteride in the previous 2 weeks and 4 months, respectively. These patients may be included if they stop those medications and replace them for tansulosin, alfuzosin or silodosin for at least 2 weeks and 4 months, respectively. Any mental condition or disorder that would interfere with the subject's ability to provide informed consent Participation in a study of any investigational drug or device in the previous 3 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

João M Pisco, M.D,. Ph.D.

Organizational Affiliation

Hospital de Saint Louis

Official's Role

Study Director

Facility Information:

Facility Name

Hospital de Saint Louis

City

Lisboa

ZIP/Postal Code

1200-249 Lisboa

Country

Portugal

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Deidentified participant data and data dictionary of all the study data.

IPD Sharing Time Frame

From January 2020

IPD Sharing Access Criteria

Deidentified participant data and data dictionary will be made available upon request to oliveira.amg@gmail.com with the submission of a study protocol and subsequent approval by the Research Ethics Committee of the institution where the trial was conducted.

Citations:

PubMed Identifier

31831295

Citation

Pisco JM, Bilhim T, Costa NV, Torres D, Pisco J, Pinheiro LC, Oliveira AG. Randomised Clinical Trial of Prostatic Artery Embolisation Versus a Sham Procedure for Benign Prostatic Hyperplasia. Eur Urol. 2020 Mar;77(3):354-362. doi: 10.1016/j.eururo.2019.11.010. Epub 2019 Dec 10.

Results Reference

result

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Clinical Trial of Prostatic Arterial Embolization Versus a Sham Procedure to Treat Benign Prostatic Hyperplasia

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